Recruiting

GAHT

Sponsor:

University of Wisconsin, Madison

Code:

NCT07624747

Conditions

Gender Dysphoria

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Magnetic Resonance Imaging

Cognition and Health Tests

Optional Exercise Test

Study Details

Brief summary:

The purpose of this study is to test whether and how a person's brain changes in the first few months after starting gender affirming hormone therapy (GAHT). The investigators want to know if GAHT changes: 1) cerebral blood flow (CBF), 2) brain structure, connectivity, and cognitive task performance, and 3) neurocognitive function (memory, attention, executive function, processing speed). 36 male at birth and 36 female at birth participants will conduct baseline studies prior to GAHT, with a second identical set of study visits 4-6 months after GAHT begins.

Conditions

Gender Dysphoria

Study ID

NCT07624747

Start date

Oct 14, 2025

Status verified date

May, 2026

Completion date

Apr, 2028

Anticipated

Primary completion date

Apr, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

Inclusion Criteria:

  • intention to undergo GAHT

Exclusion Criteria:

  • BMI greater than 40 kg/m2
  • Age greater than 45 yrs
  • Blood pressure greater than 140/90 (stage II hypertension)
  • A current diagnosis of type II diabetes
  • History of traumatic brain injury/concussion, stroke, or seizures
  • Are post-menopausal
  • Previously taken hormone therapy medications
  • Self-reported pregnancy (no pregnancy test)

Study Design

Enrollment

72 participants

Anticipated

Interventions and Outcome Measures

Arms

Male at birth undergoing GAHT with their Clinical Care Team

Female at birth undergoing GAHT with their Clinical Care Team

Interventions

Magnetic Resonance Imaging

Two MRI visits (baseline and after 4-6 months of continuous GAHT) will involve structural scans of the brain, scans while performing cognitive tasks, and a scan taken while responding to an inhaled CO2 stressor. This visit will take approximately 1.5 hours.

Cognition and Health Tests

Two cognition and health test trials (baseline and after 4-6 months of continuous GAHT) will involve a body composition scan to determine body fat percentage, muscle mass, and bone density. This will be followed by a set of cognitive tasks using the NIH Toolbox.

Optional Exercise Test

Optional graded exercise test will be performed if the participant consents to this optional procedure (baseline and after 4-6months of continuous GAHT). to determine cardiorespiratory fitness. This test will be performed on a cycle ergometer, with a metabolic allowing for the measurement of maximal oxygen consumption via indirect calorimetry.

Primary outcome measure

  • Change Cerebral Blood Flow (CBF) [ Time Frame: baseline and up to 6 months (after 4-6 months of continuous GAHT) ]
  • Change in Brain Structure [ Time Frame: baseline and up to 6 months (after 4-6 months of continuous GAHT) ]
  • Change in Brain Connectivity [ Time Frame: baseline and up to 6 months (after 4-6 months of continuous GAHT) ]
  • Change in Cognitive Function: Flanker Inhibitory Control and Attention [ Time Frame: baseline and up to 6 months (after 4-6 months of continuous GAHT) ]
  • Change in Cognitive Function: Pattern Comparison Processing Speed Test [ Time Frame: baseline and up to 6 months (after 4-6 months of continuous GAHT) ]
  • Change in Cognitive Function: List Sorting Working Memory Test [ Time Frame: baseline and up to 6 months (after 4-6 months of continuous GAHT) ]
  • Change in Cognitive Function: Dimensional Change Card Sort Test [ Time Frame: baseline and up to 6 months (after 4-6 months of continuous GAHT) ]
  • Change in Cognitive Function: Picture Vocabulary Test [ Time Frame: baseline and up to 6 months (after 4-6 months of continuous GAHT) ]

Central Contacts and Locations

Central contacts

Shawn Bolin, MS

608-263-6308sbolin@wisc.edu

Locations

UW School of Medicine and Public Health

Recruiting

Madison, Wisconsin, United States, 53792

More Information

Sponsor

University of Wisconsin, Madison

Last update posted

Jun 3, 2026

Last verified

May, 2026

Keywords

  • Gender-Affirming Hormone Therapy
  • brain health

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-08. This information was provided to ClinicalTrials.gov by University of Wisconsin, Madison on 2026-06-03. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.